Policies & Legislation

COSTEFF: Parallel trade, generics, biosimilars and home care can reduce European healthcare costs

Home/Policies & Legislation | Posted 17/11/2009

We are all familiar with the pressures piling up on healthcare systems around the world. People are living longer and diseases of ageing, such as dementia, are becoming more prevalent. Some illnesses linked to lifestyle, such as diabetes, are also on the rise.

US Senate panel votes to outlaw ‘pay-for-delay’ deals

Home/Policies & Legislation | Posted 16/11/2009

The US Senate Judiciary Committee has voted 12-7 in favour of legislation to outlaw deals agreed between branded drugmakers and generics firms to delay the entry of generic competitors to the market.

Indian firms race to sell generic oseltamivir

Home/Policies & Legislation | Posted 29/10/2009

With the Indian government permitting ‘restricted’ sales of oseltamivir, a generic version of Roche's Tamiflu for influenza A H1N1, the domestic market is seeing a flurry of activity as Indian firms move to stock their products at retail pharmacies.

US court upholds Lilly’s Evista (raloxifene) patents through 2014, blocking Teva’s generic

Home/Policies & Legislation | Posted 26/10/2009

A US federal judge has upheld Lilly's method-of-use patents for its osteoporosis drug Evista (raloxifene) through to March 2014, blocking an attempt by Teva Pharmaceutical Industries to sell a generic version. The product has annual US sales of around US$650 million (Euros 442 million). Teva said it plans to appeal the decision.

Generic drugmakers criticise US health plan rebates

Home/Policies & Legislation | Posted 20/10/2009

The US government could save more money by increasing the use of cheaper generic drugs rather than hiking rebates paid by manufacturers, an industry executive said on 17 September 2009.

Roche and Amgen agree on temporary Mircera import ban

Home/Policies & Legislation | Posted 20/10/2009

Roche has agreed not to oppose Amgen's request for a limited exclusion order that would block the import of Roche's anaemia drug Mircera into the US Amgen filed a motion recently with the US International Trade Commission (ITC) asking for a summary determination that Roche had violated a section of the Smoot-Hawley Tariff Act by importing the pegylated erythropoietin product Mircera (methoxy polyethylene glycol-epoetin beta), which Amgen claims infringes its patents.

EU assures India to take steps to resolve drug seizure cases

Home/Policies & Legislation | Posted 19/10/2009

The EU has assured India that it will take steps to resolve the issue related to the recent cases of life-saving generic or off-patent medicines exported from India to other countries being seized at European ports, but would prefer not to do so through a legal battle at the World Trade Organization (WTO).

Biosimilars advancing along European approval path

Home/Policies & Legislation | Posted 04/09/2009

With an EU regulatory framework in place to address the safety of biosimilars – also known as follow-on biologics (FOBs) – the opportunity represented by these products has been proven, and it is growing, as reported by Cynthia Challener in ICIS Chemical Business.

WHO has prequalification multisource (generic) guideline

Home/Policies & Legislation | Posted 31/08/2009

On 18 June 2009, WHO published a Prequalification Update, informing that a guideline on submission of documentation for prequalification of multisource (generic) has been completed and that Finished Pharmaceutical Products (FPPs) will be approved by Stringent Regulatory Authorities (SRAs). It states that WHO recognises the scientific evaluation of multisource (generic) products by regulatory authorities, which apply similarly stringent standards for quality, safety and efficacy as those recommended by WHO.

US bill proposes Comparative-Effectiveness Research Centre

Home/Policies & Legislation | Posted 31/08/2009

Mr Randall Stafford of the Stanford Prevention Research Center and Mr Caleb Alexander of the University of Chicago, USA have published several challenges that must be met if comparative-effectiveness research (CER) is to be useful in significantly improving the quality and affordability of US health care. In the 17 June 2009 issue of the Journal of the American Medical Association they write, “Researchers, policy makers, insurers, and other stakeholders have voiced enthusiasm about the value of CER that rigorously evaluates two or more drugs or devices. The most recent boost for these efforts has been the US congressional financial stimulus package that contains provisions for US$1.1 billion (Euros 787.4 million) to be devoted to this effort. The appeal of CER is undeniable. If there is one issue that stakeholders agree about, it is that increasing healthcare costs are ultimately unsustainable and society needs more value for its money. However, it is not clear whether CER, as it is commonly framed, has a comparative advantage when it comes to improving the US healthcare system. If CER is to succeed, future initiatives will need to generate data prior to the widespread adoption of a drug or device.”